Commission Implementing Regulation (EU) No 1065/2012 of 13 November 2012 concerning the authorisation of preparations of Lactobacillus plantarum (DSM 23375, CNCM I-3235, DSM 19457, DSM 16565, DSM 16568, LMG 21295, CNCM MA 18/5U, NCIMB 30094, VTT E-78076, ATCC PTSA-6139, DSM 18112, DSM 18113, DSM 18114, ATCC 55943 and ATCC 55944) as feed additives for all animal species Text with EEA relevance

• CELEX: Implementing Regulation (EU) No 1065/2012
• Articles: 4

Article 1 Authorisation

The preparations specified in the Annex belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 Transitional measures

The preparations specified in the Annex and feed containing them, which are produced and labelled before 4 June 2013 in accordance with the rules applicable before 4 December 2012 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 3 Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

CFU/kg of fresh material

Category of technological additives. Functional group: silage additives

1k20716

—

Lactobacillus plantarum (DSM 23375)

Additive composition

Preparation of Lactobacillus plantarum (DSM 23375) containing a minimum of 2 × 10 10 CFU/g additive

Characterisation of the active substance

Lactobacillus plantarum (DSM 23375)

Analytical method

( 1 )

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)

Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).

All animal species

—

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2.

Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 10 8 CFU/kg fresh material.

3.

For safety: it is recommended to use breathing protection and gloves during handling.

4 December 2022

1k20717

—

Lactobacillus plantarum (CNCM I-3235)

Additive composition

Preparation of Lactobacillus plantarum (CNCM I-3235) containing a minimum of 5 × 10 10 CFU/g additive

Characterisation of the active substance

Lactobacillus plantarum (CNCM I-3235)

Analytical method

( 1 )

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)

Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).

All animal species

—

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2.

Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 2 × 10 7 CFU/kg fresh material.

3.

For safety: it is recommended to use breathing protection and gloves during handling.

4 December 2022

1k20718

—

Lactobacillus plantarum (DSM 19457)

Additive composition

Preparation of Lactobacillus plantarum (DSM 19457) containing a minimum of 1 × 10 10 CFU/g additive

Characterisation of the active substance

Lactobacillus plantarum (DSM 19457)

Analytical method

( 1 )

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)

Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).

All animal species

—

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2.

Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 5 × 10 7 CFU/kg fresh material.

3.

For safety: it is recommended to use breathing protection and gloves during handling.

4 December 2022

1k20719

—

Lactobacillus plantarum (DSM 16565)

Additive composition

Preparation of Lactobacillus plantarum (DSM 16565) containing a minimum of 5 × 10 10 CFU/g additive

Characterisation of the active substance

Lactobacillus plantarum (DSM 16565)

Analytical method

( 1 )

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)

Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).

All animal species

—

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2.

Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 10 8 CFU/kg fresh material.

3.

For safety: it is recommended to use breathing protection and gloves during handling.

4 December 2022

1k20720

—

Lactobacillus plantarum (DSM 16568)

Additive composition

Preparation of Lactobacillus plantarum (DSM 16568) containing a minimum of 5 × 10 10 CFU/g additive

Characterisation of the active substance

Lactobacillus plantarum (DSM 16568)

Analytical method

( 1 )

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)

Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).

All animal species

—

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2.

Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 10 8 CFU/kg fresh material.

3.

For safety: it is recommended to use breathing protection and gloves during handling.

4 December 2022

1k20721

—

Lactobacillus plantarum (LMG 21295)

Additive composition

Preparation of Lactobacillus plantarum (LMG 21295) containing a minimum of 5 × 10 10 CFU/g additive

Characterisation of the active substance

Lactobacillus plantarum (LMG 21295)

Analytical method

( 1 )

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)

Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).

All animal species

—

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2.

Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 10 8 CFU/kg fresh material.

3.

For safety: it is recommended to use breathing protection and gloves during handling.

4 December 2022

1k20722

—

Lactobacillus plantarum (CNCM MA 18/5U)

Additive composition

Preparation of Lactobacillus plantarum (CNCM MA 18/5U) containing a minimum of 2 × 10 10 CFU/g additive

Characterisation of the active substance

Lactobacillus plantarum (CNCM MA 18/5U)

Analytical method

( 1 )

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)

Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).

All animal species

—

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2.

Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 10 8 CFU/kg fresh material.

3.

For safety: it is recommended to use breathing protection and gloves during handling.

4 December 2022

1k20723

—

Lactobacillus plantarum (NCIMB 30094)

Additive composition

Preparation of Lactobacillus plantarum (NCIMB 30094) containing a minimum of 5 × 10 10 CFU/g additive

Characterisation of the active substance

Lactobacillus plantarum (NCIMB 30094)

Analytical method

( 1 )

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)

Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).

All animal species

—

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2.

Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 10 9 CFU/kg fresh material.

3.

For safety: it is recommended to use breathing protection and gloves during handling.

4 December 2022

1k20724

—

Lactobacillus plantarum (VTT E-78076)

Additive composition

Preparation of Lactobacillus plantarum (VTT E-78076) containing a minimum of 1 × 10 11 CFU/g additive

Characterisation of the active substance

Lactobacillus plantarum (VTT E-78076)

Analytical method

( 1 )

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)

Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).

All animal species

—

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2.

Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 10 9 CFU/Kg fresh material.

3.

The additive shall be used in easy and moderately difficult to ensile material  ( 2 ) .

4.

For safety: it is recommended to use breathing protection and gloves during handling.

4 December 2022

1k20725

—

Lactobacillus plantarum (ATCC PTSA-6139)

Additive composition

Preparation of Lactobacillus plantarum (ATCC PTSA-6139) containing a minimum of 1 × 10 10 CFU/g additive

Characterisation of the active substance

Lactobacillus plantarum (ATCC PTSA-6139)

Analytical method

( 1 )

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)

Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).

All animal species

—

—

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2.

Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 2 × 10 7 CFU/kg fresh material.

3.

The additive shall be used in easy to ensile material  ( 3 ) .

4.

For safety: it is recommended to use breathing protection and gloves during handling.

4 December 2022

1k20726

—

Lactobacillus plantarum (DSM 18112)

Additive composition

Preparation of Lactobacillus plantarum (DSM 18112) containing a minimum of 1 × 10 10 CFU/g additive

Characterisation of the active substance

Lactobacillus plantarum (DSM 18112)

Analytical method

( 1 )

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)

Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).

All animal species

—

—

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2.

Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 5 × 10 6 CFU/kg fresh material.

3.

The additive shall be used in easy to ensile material  ( 3 ) .

4.

For safety: it is recommended to use breathing protection and gloves during handling.

4 December 2022

1k20727

—

Lactobacillus plantarum (DSM 18113)

Additive composition

Preparation of Lactobacillus plantarum (DSM 18113) containing a minimum of 1 × 10 10 CFU/g additive

Characterisation of the active substance

Lactobacillus plantarum (DSM 18113)

Analytical method

( 1 )

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)

Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).

All animal species

—

—

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2.

Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 2 × 10 7 CFU/kg fresh material.

3.

The additive shall be used in easy to ensile material  ( 3 ) .

4.

For safety: it is recommended to use breathing protection and gloves during handling.

4 December 2022

1k20728

—

Lactobacillus plantarum (DSM 18114)

Additive composition

Preparation of Lactobacillus plantarum (DSM 18114) containing a minimum of 1 × 10 10 CFU/g additive

Characterisation of the active substance

Lactobacillus plantarum (DSM 18114)

Analytical method

( 1 )

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)

Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).

All animal species

—

—

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2.

Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 2 × 10 7 CFU/kg fresh material.

3.

The additive shall be used in easy to ensile material  ( 3 ) .

4.

For safety: it is recommended to use breathing protection and gloves during handling.

4 December 2022

1k20729

—

Lactobacillus plantarum (ATCC 55943)

Additive composition

Preparation of Lactobacillus plantarum (ATCC 55943) containing a minimum of 1 × 10 10 CFU/g additive

Characterisation of the active substance

Lactobacillus plantarum (ATCC 55943)

Analytical method

( 1 )

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)

Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).

All animal species

—

—

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2.

Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 2 × 10 7 CFU/kg fresh material.

3.

The additive shall be used in easy to ensile material  ( 3 ) .

4.

For safety: it is recommended to use breathing protection and gloves during handling.

4 December 2022

1k20730

—

Lactobacillus plantarum (ATCC 55944)

Additive composition

Preparation of Lactobacillus plantarum (ATCC 55944) containing a minimum of 1 × 10 10 CFU/g additive

Characterisation of the active substance

Lactobacillus plantarum (ATCC 55944)

Analytical method

( 1 )

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787)

Identification in the feed additive: pulsed-field gel electrophoresis (PFGE).

All animal species

—

—

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2.

Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 5 × 10 6 CFU/kg fresh material.

3.

The additive shall be used in easy to ensile material  ( 3 ) .

4.

For safety: it is recommended to use breathing protection and gloves during handling.

4 December 2022

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx

( 2 )   Easy to ensile forage: > 3 % soluble carbohydrates in fresh material (e.g. whole plant maize, ryegrass, brome grass or sugar beet pulp). Moderately difficult to ensile forages: 1,5-3,0 % soluble carbohydrate in fresh material (e.g. meadow grass, fescue or wilted alfalfa). Commission Regulation (EC) No 429/2008 ( OJ L 133, 22.5.2008, p. 1 ).

( 3 )   Easy to ensile forage: > 3 % soluble carbohydrates in fresh material (e.g. whole plant maize, ryegrass, brome grass or sugar beet pulp). Regulation (EC) No 429/2008.